CodaRecalls & reported problems across all models
Cook Incorporated · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 70
- Deaths reported
- 2
- Injuries reported
- 3
- Recalls
- 0
We found 6 models of Coda by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Feb 20, 2017 and Aug 17, 2026 — classified as 2 deaths, 3 injuries, 65 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (35 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Coda problems
Device problems
- Material Rupture35
- Difficult to Advance7
- Inflation Problem7
- Device Contaminated During Manufacture or Shipping6
- Adverse Event Without Identified Device or Use Problem3
- Device Operates Differently Than Expected3
- Fluid/Blood Leak3
- Leak/Splash3
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Known Impact Or Consequence To Patient23
- No Consequences Or Impact To Patient14
- No Patient Involvement4
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cardiac Arrest1
- Death1
Coda models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Coda G03831CATHETER, PERCUTANEOUS2 deaths29 reports
- Coda G53024CATHETER, PERCUTANEOUS15 reports
- Coda G03832CATHETER, PERCUTANEOUS9 reports
- Coda G23773CATHETER, PERCUTANEOUS7 reports
- Coda G36042CATHETER, PERCUTANEOUS5 reports
- Coda G53025CATHETER, PERCUTANEOUS5 reports
Recent Coda adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50282079 ↗MalfunctionApr 20, 2026Material Rupture
IT WAS REPORTED THAT THE CODA LP BALLOON CATHETER RUPTURED DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) PROCEDURE FOR AN UNKNOWN PATIENT. FOLLOWING COMPETITOR STENT GRAFT DEPLOYMENT, THE BALLOON RUPTURED IMMEDIATELY UPON INFLATION DURING PROXIMAL TOUCH-UP. A BACKUP CODA BALLOON WAS USED TO PERFORM THE PLANNED TOUCH-UP, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ENDOLEAKS. IT WAS NOTED THAT AIR REMOVAL WAS PERFORMED BY THE NURSING STAFF. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924334 ↗MalfunctionJan 15, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A COOK CODA BALLOON CATHETER CONTAINED FOREIGN MATTER. DURING A COOK ZENITH FENESTRATED PROCEDURE, THE DEVICE WAS OPENED FOR USE. WHEN THE DEVICE PACKAGE WAS OPENED, FOREIGN MATTER, RESEMBLING HAIR WAS FOUND INSIDE THE PACKAGING BY THE CAP THAT COMES ON THE BALLOON. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24079972 ↗DeathJan 6, 2026Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT NO LONGER MEETS THE CRITERIA FOR A REPORTABLE EVENT. SEE H11.
Patient problems: Cardiac Arrest
MAUDE report 23981359 ↗MalfunctionDec 11, 2025Difficult to Advance; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23781162 ↗MalfunctionDec 1, 2025Material Rupture; Material Rupture
IT WAS REPORTED TO COOK THAT AIR LEAKED FROM A COOK CODA LP BALLOON CATHETER. THE COOK CODA LP BALLOON CATHETER WAS BEING PREPPED FOR USE FOR TOUCH UP DURING AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE. WHEN SALINE WAS INJECTED TO REMOVE AIR, THE BALLOON LEAKED. A COOK CODA LP BALLOON CATHETER FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687685 ↗MalfunctionNov 12, 2025Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532355 ↗MalfunctionOct 27, 2025Difficult to Advance; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393163 ↗MalfunctionSep 12, 2025Material Rupture; Material Rupture
ADDITIONAL INFORMATION WAS PROVIDED ON 10SEP2025. THE BALLOON WAS INFLATED ON THE PROXIMAL SIDE OF THE GRAFT. THERE WAS NO ANGULATION OR VESSEL CALCIFICATION AT OR NEAR THE INFLATION SITE. IMAGING, PLANNING AND SIZING, NOR PHOTOS OF THE DEVICE CAN BE PROVIDED FOR THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23043053 ↗MalfunctionAug 12, 2025Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786255 ↗MalfunctionAug 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A HAIR-LIKE FIBER WAS FOUND IN THE STERILE PACKAGING OF A CODA BALLOON CATHETER PRIOR TO USE. AFTER ENDOLUMINAL STENTING OF AN ABDOMINAL AORTIC ANEURYSM, WHILE PREPARING FOR POST-STENT DILATATION WITH COOK'S CODA BALLOON, THE HAIR-LIKE FIBER WAS FOUND IN THE PRODUCT'S STERILIZED PACKAGE. THE PRODUCT WAS NOT USED, AND A NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22704960 ↗MalfunctionJul 28, 2025Material Rupture; Material Rupture
COOK WAS NOTIFIED THAT A COOK CODA LP BALLOON CATHETER RUPTURED DURING AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE. A COMPETITOR'S GRAFT (28 X 70) WAS INSERTED FROM THE RIGHT FEMORAL ARTERY AND THE CUFF OF THE GRAFT WAS PLACED JUST BELOW THE KIDNEY. ANOTHER COMPETITOR'S CUFF (28 X 16 X 45) WAS PLACED ABOUT ONE TO TWO CENTIMETERS BELOW THE CUFF. AFTER PLACEMENT ON THE CONTRALATERAL AND IPSILATERAL SIDES, THE COOK CODA LP BALLOON WAS INFLATED TO 25 CC USING CONTRAST MEDIA AND APPLIED TO THE CENTRAL AREA. WHEN PRESSURE WAS APPLIED TO THE OVERLAPPING AREA OF THE CUFF AND THE MAIN BODY, THE COOK CODA LP BALLOON CATHETER RUPTURED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22637481 ↗InjuryJul 14, 2025Use of Device Problem; Use of Device Problem
COOK WAS NOTIFIED THAT A RUPTURE OF THE ABDOMINAL AORTA OCCURRED AFTER BALLOONING WITH A COOK CODA BALLOON. THE INDICATION FOR THE ELECTIVE PROCEDURE WAS A POST-DISSECTING THORACIC ABDOMINAL AORTIC ANEURYSM (TAAA) TYPE I EXTENT, CRAWFORD CLASSIFICATION. A RESCUE REPAIR HAD BEEN PERFORMED AFTER PRIOR OPEN REPAIR WITH A THORACIC SURGICAL GRAFT FOR A TYPE A DISSECTION. PRE-PROCEDURAL COMPUTED TOMOGRAPHY (CT) WITH CONTRAST IMAGING WAS COMPLETED ON (B)(6) 2024 (151 DAYS PRIOR TO THE PROCEDURE). THE BILATERAL COMMON ILIAC AND INTERNAL ILIAC ARTERIES WERE PATENT. THE BILATERAL VERTEBRAL ARTERIES WERE PATENT. THE AORTIC VALVE WAS NATIVE. THE MAXIMUM DIAMETER OF THE DISEASED AORTA ON CENTER LINE WAS 68 MM. THE INTENDED PROXIMAL LANDING ZONE WAS ZONE 2: LEFT COMMON CAROTID TO LEFT SUBCLAVIAN ARTERY. THE INTENDED DISTAL LANDING ZONE WAS ZONE 5: MID DESCENDING AORTA TO CELIAC ARTERY. THE PATIENT UNDERWENT THE FIRST PROCEDURE OF THE STAGED PROCEDURES ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA) AT THE TIME OF THE PROCEDURE. PERCUTANEOUS ACCESS WAS ACHIEVED IN THE RIGHT AND LEFT FEMORAL ARTERIES. THE LEFT FEMORAL VEIN WAS ACCESSED FOR CARDIAC RAP
Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding; Paraplegia; Shock; Spinal Cord Injury
MAUDE report 22500445 ↗MalfunctionJun 19, 2025Material Rupture; Material Rupture
ADDITIONAL INFORMATION WAS PROVIDED ON 10SEP2025. THERE WAS NO ANGULATION AT THE INFLATION SITE ON THE PRE-OPERATIVE SCAN OR ON THE CONTROL X-RAY AFTER POSITIONING THE BALLOON. THE THORACIC AORTA DID NOT SHOW ANY LARGE CALCIFICATIONS ON THE PRE-OPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN, NOR WERE THEY VISIBLE ON THE CHEST X-RAY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22289719 ↗MalfunctionJun 18, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE CODA BALLOON CATHETER WAS UNABLE TO BE ADVANCED DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) PROCEDURE FOR AN UNKNOWN PATIENT. THE CODA WAS TO BE USED FOR TOUCH-UP; HOWEVER, IT BECAME IMPOSSIBLE TO ADVANCE INSIDE THE BODY OF THE PATIENT. THE COMPLAINT DEVICE WAS THEN REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE ON THE OTHER SIDE, BUT STRONG RESISTANCE WAS STILL FELT. THERE WAS CONCERN BY THE PHYSICIAN THAT CONTINUED ATTEMPTS WOULD MAKE THE CATHETER IMPOSSIBLE TO REMOVE, SO THE USE OF THE CODA WAS STOPPED. A BALLOON CATHETER FROM ANOTHER MANUFACTURER WAS USED TO SUCCESSFULLY TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288140 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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